ZOLL SOLEX 7 Intravascular Catheter Kit Recalled for Potential Leakage
ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The score of 3 (High) applies because this is a risk-of-harm medical device (intravascular catheter with potential leak hazard) where no illnesses or injuries have been reported. A leaking intravascular catheter poses clinical risk, but the absence of reported harm and lack of FDA Class I classification prevent a Severe rating.
Plain-English summary
ZOLL Circulation, Inc. is recalling the SOLEX 7 Intravascular Heat Exchange Catheter Kit (REF: 8700-0793-14, model SL-2593CO, Heparin COATED) with central venous infusion capabilities. The recalled product involves 98 units distributed worldwide, including across all US states and to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots are affected.
The recall is due to potential leaks from the catheter or the start-up kit (SUK) tubing. ZOLL has issued a labeling update to address this safety concern.
Users of the SOLEX 7 catheter kits should be aware of the potential leak hazard. Contact ZOLL Circulation, Inc. for additional information regarding the labeling update and any necessary actions. The recalled product is a prescription-only medical device.
The recalled product
- Product
- Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 98
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 28 recalled by ZOLL Circulation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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